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“Study of Several Well-Publicized Instrument-Reprocessing breaches within the

Veterans Health Administration.”

Tennessee SGNA’s29th Annual Educational Course

Embassy Suites820 Crescent Centre Drive

Franklin, TN

Saturday, October 15 -17, 20108:15a - 9:15a

Founder: www.MyEndoSite.com and “The Q-Net Monthly.”

Lawrence F. Muscarella, Ph.D.Director, Research and Development

Custom Ultrasonics, Inc.

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THIS LECTURE’S OBJECTIVES:

The primary objectives of this morning’s lecture are to:

1. Discuss the infection-control breaches identified at three VA medical centers (VAMCs) located in Murfreesboro, TN; Augusta, GA; and Miami, FL.

2. Focus on the clinical significance and root causes of the breaches identified in Murfreesboro (TN).

3. Briefly discuss the reprocessing breach identified at the VAMC located in San Juan, Puerto Rico, and the VAMC located in St. Louis, MO.

4. Provide recommendations to prevent infection during flexible and GI endoscopy.

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BACKGROUND

In 2008 and 2009, reprocessing breaches involving flexible endoscopes were identified at 3 different medical centers within the Veterans Health Administration (VHA).

– These 3 VA medical centers (VAMCs) are located in:

(1) Murfreesboro, TN; (2) Miami, FL; and (3) Augusta, GA.

Reports note that these breaches may have exposed more than 10,000 patients to infectious agents – including HIV and the hepatitis B and C viruses.

› One patient is suing the VA for $10 million, alleging she contracted hepatitis C at the VA in Augusta (GA) from an improperly cleaned flexible laryngoscope.*

* Source: The Augusta Chronicle. July 6, 2010.

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1. What happened in Murfreesboro, Tennessee?

A. In December, 2008, several infection-control breaches were identified at the VAMC in Murfreesboro, TN (Alvin C. York Campus).

› Blood was observed in the auxiliary water system used during colonoscopy.

Breach: An investigation confirmed that for as many as 5 years:

› this VAMC had been misusing the Olympus MAJ-855 Auxiliary Water Tube such that:

1) instead of being fitted with the requisite one-way valve, the MAJ-855 irrigation tubing had been:

— fitted with an improper two-way connector, permitting the back-flow of blood into the MAJ-855 tubing.

Auxiliary water system

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Enlarged diagram of happened in Murfreesboro, TN

Enlarged: The Olympus auxiliary water system used during colonoscopy. *

* Source: VA Office of Inspector General. Use and Reprocessing of Flexible Fiber-optic Endoscopes at VA Medical Facilities. Report No. 09-01784-146 June 16, 2009. Washington, DC 20420.

1) the MAJ-855 Auxiliary Water Tube

2) Its one-way valve

3) The short (“OFP”) irrigation tube

4) The Olympus flushing pump (OFP)

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A 2nd diagram of what happened in Murfreesboro, TN

This is Olympus’s MAJ-855 Auxiliary Water Tube used

for irrigation

Note the MH-974’s single-winged

valve, which allows bi-directional

flow.

Note the MAJ-855’s correct valve - which is double-winged and

restricts flow in the wrong direction.

This is Olympus’s MH-974

Washing Tube

Images from: VA Patient Safety Alert. 12-22-08; AL09-07.

Note: Ensure that these two valves

are not being switched and used interchangeably.

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1. What happened in Murfreesboro, Tennessee?

› This investigation also determined that for as many as 5 years this VAMC in Murfreesboro had been:

2) improperly reprocessing the MAJ-855 tubing.

— Specifically, this tubing was cleaned and high-level disinfected (or steam sterilized)

› only once at the end of the day,

not after each patient procedure (whether or not the auxiliary water system was used during the procedure).*

* Source: Olympus America. Important Safety Notice. February 11, 2009. Pages 1-4.

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1. What happened in Murfreesboro, Tennessee?

3) And, third, the short OFP irrigation tube - that connects the MAJ-855 to a OFP flushing pump - was not discarded at the end of the day, but was typically reused.

Infection risk: The improper fitting of the MAJ-855 tubing with the MH-974’s similar-in-appearance two-way connector (instead of the correct one-way valve) can facilitate:

› the “back-flow” of blood and other potentially infectious debris from the patient’s colon into the MAJ-855 auxiliary water tube.

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1. What happened in Murfreesboro, Tennessee?

The contamination of the MAJ-855 tubing,

› coupled with the failure to clean and high-level disinfect (or sterilize) it after each patient procedure

— can result in the patient-to-patient transmission of such infectious agents as the hepatitis C virus.

Further, failure to throw out the short OFP irrigation tube at the end of each day similarly poses an increased risk of its contamination and of patient infection.

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2. What happened in Miami, Florida?

B. Infection-control breaches were also identified the next month at the VAMC in Miami, FL, in January, 2009 (Bruce W. Carter VAMC).

› As a result of the publicized breaches in TN, an inspection was performed at this VAMC in FL, to certify compliance with the VHA’s procedures for endoscope reprocessing.

Breach: During this inspection, this VAMC discovered that for as many as 5 years:

1) it, too, had not been reprocessing the Olympus MAJ-855 auxiliary water tube after each procedure.

— Rather, this VAMC had been merely rinsing the MAJ-855 tubing with (sterile) water; further …

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2. What happened in Miami, Florida?

2) This VAMC often connected the MAJ-855 tubing to the colonoscope after the procedure had already began;

3) it did not discard the short OFP irrigation tube at the end of each day. (Remember that this short tube connects the MAJ-855 tubing to the OFP flushing pump). And,

4) during this inspection, potentially infectious “debris” was identified in the auxiliary water channel of ostensibly “reprocessed” and “patient-ready” colonoscopes, indicating their improper reprocessing.

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2. What happened in Miami, Florida?

Infection risk: The failure:

a. to clean and high-level disinfect the (or steam sterilize) the MAJ-855 auxiliary water tube after each patient procedure;

b. to connect the MAJ-855 tubing to the colonoscope, with the auxiliary water system primed, prior to the procedure;

c. to discard the short OFP irrigation tube at the end of each day; and

d. to clean and high-level disinfect the colonoscope thoroughly, including its auxiliary water channel, after each procedure;

› poses an increased risk of disease transmission.

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3. What happened in Augusta, Georgia?

C. And, third, infection-control breaches were identified at the VAMC in Augusta, GA, in November, 2008 (Charlie Norwood VAMC).

› A patient in the “ENT” clinic questioned the method by which a nurse reprocessed a flexible laryngoscope.

Breach: For almost a year, this VAMC had been:

› improperly cleaning and high-level disinfecting flexible laryngoscopes between uses.

› Specifically, staff were merely wiping the external surfaces of the laryngoscope with a disposable “sanitizing” cloth - which achieves, at best, intermediate-level disinfection.

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3. What happened in Augusta, Georgia?

Infection risk: The failure to clean and, at a minimum, to high-level disinfect flexible endoscopes have been causally linked to disease transmission, with associated patient morbidity and mortality.

Briefly, flexible endoscopes, such as

› GI endoscopes and bronchoscopes

— are semi-critical instruments that require high-level disinfection or sterilization after each use.

› The use of a low-level or intermediate-level disinfectant is permitted only for non-critical items, such as bed pans and environmental surfaces.

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A root cause analysis (RCA) of the breach in TN

Let’s now focus on the VAMC in Murfreesboro, TN, and the root cause analysis (RCA) it performed and published.

› This RCA considers all of the factors that this VAMC concluded could have potentially contributed to, or caused, this VAMC’s identified breaches.

Some of the notable factors that this published RCA concludes contributed to this VAMC’s breaches include:

› that the design of the MAJ-855 tubing’s one-way valve (which is not permanently sealed in place) is too similar in shape, size, color, and appearance …

— … to the MH-974’s improper two-way connector, facilitating confusion, their interchangeable use,* and the contamination of the MAJ-855 tubing.

* Source: Root Cause Analysis (RCA) Form. Case ID: JP0141. pp. 1-4 (Dated 1/20/09)

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A root cause analysis (RCA) of the breach in TN

Some additional notable factors that this published RCA concluded contributed to the reprocessing breaches at this VAMC include:

› Manufacturer instructions that did not clearly elucidate:

— how often the MAJ-855 tubing is to be reprocessed;* and

— when the short OFP irrigation tubing is to be discarded.*

For example, after every procedure; once a day or week?

* Source: Root Cause Analysis (RCA) Form. Case ID: JP0141. pp. 1-4 (Dated 1/20/09)

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4. What happened in San Juan, Puerto Rico?

Now, let’s discuss similar reprocessing breaches that were identified during the summer of 2009 at a few medical facilities within the VA Caribbean Healthcare System.

– These medical facilities include a VAMC in San Juan (PR).

These reprocessing breaches at these several facilities

included, among others:

faulty reprocessing of transvaginal ultrasound transducers;

failure to leak test colonoscopes; and

improper reprocessing of flexible endoscopes.

To read this article, visit: www.MyEndSite.om/articles/SanJuanWeekly.pdf

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The “San Juan Weekly” * (June 24-30, 2010) reports that, as a consequence of these reprocessing breaches:

“thousands (of patients could) be at risk (of infection) in Puerto Rico and the Virgin Islands.”

Let’s focus on the infection-control breach identified at the VAMC in San Juan, PR, during the summer of 2009.

› A complaint was filed alleging that flexible laryngoscopes were not being properly reprocessed after each use.*

* Read the April-May-June, 2010, issue of “The Q-Net Monthly” for more details.

4. What happened in San Juan, Puerto Rico?

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Breach: For possibly as many as 9 months, this VAMC’s radiotherapy department had been improperly cleaning its flexible laryngoscopes after each procedure.*

› Specifically, it “cleaned” its flexible laryngoscopes by merely rinsing them with running water (followed by drying with a clean gauze pad) …

— without using a detergent.

* Source: Department of Veterans Affairs Office of Inspector General. Healthcare Inspection: Patient Safety Issues VA Caribbean Healthcare System San Juan, Puerto Rico. Report No. 09-03055-103 March 16, 2010. Washington, DC

4. What happened in San Juan, Puerto Rico?

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Infection risk: As we have discussed, the improper cleaning (and/or high-level disinfection) of flexible endoscopes have been causally associated with disease transmission.

› Further, the VAOIG investigating this breach acknowledged in its report the potential for infection whenever a flexible endoscope is improperly cleaned, stating:

— “without proper pre-cleaning, adequate (high-level) disinfection cannot be ensured.” *

I agree, and my assessment of the risk of infection associated with this specific breach is discussed in this “San Juan Weekly” front-page article.

* Source: Department of Veterans Affairs Office of Inspector General. Healthcare Inspection: Patient Safety Issues VA Caribbean Healthcare System San Juan, Puerto Rico. Report No. 09-03055-103 March 16, 2010. Washington, DC

4. What happened in San Juan, Puerto Rico?

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Let’s compare and recognize the striking similarities between this reprocessing breach identified at the VAMC in San Juan (PR) and the breach identified at the VAMC in Augusta (GA).

— In fact, the VAOIG confirmed the same breach at both VAMCs:

› namely the improper cleaning of flexible laryngoscopes.

— Yet, whereas the VHA notified 1069 patients of the breach in Augusta, it inexplicably did not notify any of the patients in San Juan of the same breach.

› In short, the VHA concluded that improper reprocessing of flexible laryngoscopes in Augusta posed an increased, if significant, risk of infection, …

while the VHA dissimilarly concluding that this same breach in San Juan pose a “negligible” risk.

4. What happened in San Juan, Puerto Rico?

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› These two incongruous assessments of risk are puzzling and have important public-health and quality-assurance implications.

› These two risk assessments led the “San Juan Weekly” to ask: “Why were patients in Puerto Rico not notified?”

› As I was quoted as saying in this newspaper article:

› “Based on the available data, the risk of infection associated with (this specific breach in San Juan) would (not) be negligible,” and would be “sufficiently significant to warrant the notification of veterans and other patients of the potential for their exposure to infectious agents.”

4. What happened in San Juan, Puerto Rico?

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5. The VAMC in St. Louis – what happened?

› That the patients at the VAMC in San Juan were not notified of its failure to use a detergent to “clean” its flexible laryngoscopes and the associated risk of infection …

› is that much more surprising, when viewed in the context, not just of the breach in Augusta, but also of the recent breach at the dental clinic of the VAMC in St. Louis (MO).

› Briefly, the VAMC in St. Louis this past July (2010) notified 1812 patients of the potential risk of infection associated with the failure to use a detergent to “clean” dental instruments, rinsing them only with water prior to sterilization.

› According to the VHA: “Because we weren't using the detergent, this might reduce the efficiency of sterilization. We just don't know.“

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Recommendations to prevent disease transmission:

Recommendations to prevent the risk of disease transmission during flexible and GI endoscopy will be presented during the lecture.

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The End

Thank you for your attention to and interest in these topics.

For questions or a list of this lecture’s references, please contact me directly at:

LFM@myendosite.com